21 CFR § 520.1782 - Pimobendan solution.

---
identifier: "/us/cfr/t21/s520.1782"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 520.1782 - Pimobendan solution."
title_number: 21
title_name: "Food and Drugs"
section_number: "520.1782"
section_name: "Pimobendan solution."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "520"
part_name: "ORAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13838, Mar. 27, 1975, unless otherwise noted."
cfr_part: "520"
---


# 520.1782 Pimobendan solution.

(a) *Specifications.* Each milliliter of solution contains 1.5 milligrams (mg) pimobendan.

(b) *Sponsor.* See No. 000010 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Administer orally at a total daily dose of 0.23 mg/lb (0.5 mg/kg) body weight. The total daily dose should be divided into two equal portions administered approximately 12 hours apart (*i.e.,* morning and evening).

(2) *Indications for use.* For the management of the signs of mild, moderate, or severe congestive heart failure in dogs due to clinical myxomatous mitral valve disease (MMVD) or dilated cardiomyopathy (DCM); for use with concurrent therapy for congestive heart failure (*e.g.,* furosemide, etc.) as appropriate on a case-by-case basis.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[89 FR 42357, May 15, 2024]